9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089); Atlas Stim Headbox (HD) (31-0601-0132); ASHB FIBER OPTIC DUPLEX CONN 2m (31-0204-0001); ASHB FIBER OPTIC DUPLEX CONN 7m (31-0204-0002); ATLAS Stim Headbox Software (36-0301-0006); Atlas Headbox Interface Cable (NK) (31-0204-003); Atlas Headbox Interface Cable (Touchproof) (31-0204-004); Atlas Headbox Interface Cable (HD) (31-0204-005); Atlas Headbox Expansion Panel (31-0607-0014)
FDA 510(k)
FDA Class 2
·Neurology
Vivid ZirDisc Zircon Zahn System
FDA UDI
PEARSON DENTAL SUPPLIES, INC.·D724Q2500941·95x28mm 03HT (Translucent)
Power Curve Extra-Soft Toothbrush
FDA UDI
SAFCO DENTAL SUPPLY CO.·10810063756403·Power Curve Extra-Soft Toothbrush, tapered head...
Good Clean Love Personal Lubricants Almost Naked and Natural Cinnamon Vanilla
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
LADY COMP USA
FDA 510(k)
FDA Unclassified
·Unknown
WHEELCHAIR ACCESSORY
FDA Adverse Event
UNKNOWN·Product code INE·September 15, 2011
R SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·August 22, 2013
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·July 26, 2013
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013